Probiotic Prophylaxis of Hirschprung's Disease Associated Enterocolitis (HAEC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Number of Patients Diagnosed With Hirschsprung-associated Enterocolitis (HAEC).
研究概览
简要总结
Prospective, randomized, controlled trial to test if post-operative administration of probiotics in HD patients will lead to a reduction in the occurrence of HAEC.
详细描述
To test the hypothesis that probiotics will decrease the risk of post pull-through enterocolitis by randomizing patients to receive either probiotics or placebo for the first 3 months after surgical treatment for HD.
E.1. Design: This study will be a prospectively performed, multi-center, double blinded, study drug versus placebo controlled study. It will test the hypothesis that post-operative administration of probiotics in HD patients will lead to a reduction in the occurrence of HAEC E.2. Study medication: VSL#3 (VSL Pharmaceuticals, Inc., Ft. Lauderdale, FL) was provided in packets, each of which contained 900 billion viable lyophilized bacteria of 4 strains of Lactobacillus (L. casei, L. plantarum, L. acidophilus, and L. delbrueckii subsp. bulgaricus), 3 strains of Bifidobacterium (B. longum, L. breve, and B. infantis), and 1 strain of Streptococcus salivarius subsp. thermophilus (designated hereafter as S. thermophilus). Maize starch was included as filler. Placebo was provided in identical bags containing 3 g of maize starch. VSL#3 and placebo were administered once each night. The taste and smell of the active drugs were not readily identifiable.
E.2.1. Formulation of the study drug: The drug will be delivered to patient's families in individual packets. The families will be instructed to administer the probiotic as appropriately diluted in 2 ounces of either expressed human milk or formula.
E.2.2. FDA approval number: VSL#3 is now a "medical food" in the US and does not need FDA approval.
E.2.3. Medication suppliers: VSL Pharmaceuticals, Inc., Ft. Lauderdale, FL E.2.4.Funds for medication: It is anticipated that the VSL Pharmaceutical Corporation will donate sufficient drug and placebo for the completion of this study. Additional funds for IRB approval and costs of dispensing drug/placebo via the Investigational Drug Service are requested from the VSL Pharmaceutical Corporation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Month 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients eligible for enrollment will include all pediatric patients suffering from HD at an age of 12 months or younger. All patients will require consent by either parent or adult guardian
排除标准
- •Patients will be excluded if children that are deemed hemodynamically unstable and require immediate operative intervention, age more than one year of age, as this may mean very delay in diagnosis and may affect the study results, or infants having major congenital anomalies with short life expectancy. Additional exclusion criteria are those patients' parents or adult guardian who refuse to undergo randomization. Finally, those children who are transferred to another non-participating hospital will be excluded.
研究组 & 干预措施
1
VSL#3 probiotic
干预措施: VSL#3 (Drug)
2
Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Patients Diagnosed With Hirschsprung-associated Enterocolitis (HAEC).
时间窗: 6 months post-pullthrough
The primary outcome measure is reporting the number of participants diagnosed with Hirschsprung-associated enterocolitis (HAEC) after pullthrough procedure.
Severity of Clinical Episodes of HAEC
时间窗: 6 months
The severity of clinical episodes of HAEC will be stratified into three grades (mild, moderate, or severe). Grades of severity reported are based on first episodes.
次要结局
未报告次要终点
研究者
Daniel H. Teitelbaum
Professor of Surgery
University of Michigan